Monitoring


Clinical trials, ranging from simple to high complexity in assumption and structure, are initiated and conducted at acromion GmbH, realising a large scale of different therapeutic indications.

 

Our educated and skilled clinical research associate team has outstanding qualification and experience.

 

Our monitoring activities include: 

 

  • identification and assessment of potential sites 
  • collection and processing of essential documents  
  • preparation and conduct of initiation visits 
  • review and presentation of trial material 
  • training of site personnel 
  • preparation and conduct of periodic monitoring visits 
  • motivation of investigative staff 
  • control of protocol compliance 
  • CRF-check and SDV 
  • monitoring of timely and complete SAE/AE reporting 
  • support in query resolution
  • control of drug accountability, drug and non-drug supplies 
  • review and maintenance of investigator files 
  • audit preparation of trial sites and resolution of audit findings 
  • documentation of all activities 
  • processing and administration of investigator payments
  • preparation and conduct of close-out visits 

 

 

Key qualification factors for our monitoring team are:

 

  • profound experience in clinical research 
  • intent accuracy and focused attention to details 
  • strong communication abilities 
  • highly developed organisational skills 
  • enthusiasm
  • profound computer skills 
  • preparedness for on-site presence for a specified period of time
  • working language skills in German and English, and ideally a third language; 

 

 

Languages currently represented at acromion GmbH by native speakers are German and English, French, Italian, Dutch, Spanish, Polish, Greek, Hungarian, Romanian. 

 

This fact reinforces GCP conform monitoring and source data verification of clinical data from your international clinical trials.

 

Your Contact

Julita Kelm-Wozniak

CRA Manager

acromion GmbH
 

Europaallee 27-29

50226 Frechen
 

Tel: +49 (0)2234-20 37 37-0

Fax: +49 (0)2234-20 37 37-9


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